Medical surgical device with counter for recording usage

ABSTRACT

Medical device having a counter for recording usage. A medical tool is provided having a proximal extremity. The tool having a collar fixed thereto and a cap. The cap includes a part which requires replacement and/or cleaning for each use of the tool. A detent assembly is carried by the cap and the collar and includes a rotatable counter wheel and a mechanism for causing advancement of the counter wheel from one number to the next number when the cap is separated from the collar so that the counter wheel is advanced by one increment each time the cap is removed and/or replaced on the collar to give an indication of the number of times that the device has been used.

This is a continuation of application Ser. No. 08/080,754 filed Jun. 22,1993, now U.S. Pat. No. 5,448,042.

This invention relates to a surgical device with a counter for recordingusage.

Various types of medical devices have heretofore been provided, as forexample tools which are utilized in laparoscopic surgery. With suchmedical devices a need has arisen for ascertaining the number of times atool has been used, particularly where the tool is of a reusable typebut has a limited lifetime. Such usage counting is particularlydesirable for warranty purposes.

In general, it is an object of the present invention to provide amedical device, which is provided, with a counter for recording usage.

Another object of the invention is to provide a medical device of theabove character which requires sterilization and/or cleaning before eachuse.

Another object of the invention is to provide a medical device of theabove character which utilizes a removable part which must be removedfor cleaning and/or sterilization purposes and must be replaced forreuse of the medical device.

Another object of the invention is to provide a medical device of theabove character in which the counter is advanced by one increment eachtime the removable part is removed.

Another object of the invention is to provide a medical device of theabove character in which the removable part includes a cap.

Another object of the invention is to provide a medical device of theabove character in which the counter is very compact and is disposedwithin the normal outlines of the medical device.

Additional objects and features of the invention will appear from thefollowing description in which the preferred embodiments are set forthin detail in conjunction with the accompanying drawing.

FIG. 1 is a side elevational view of a tool actuator which has anmounted therein a medical device or tool which is provided with acounter for recording usage with certain portions being shown in crosssection.

FIG. 2 is a partially exploded view partially in cross section of themedical device shown in FIG. 1.

FIG. 3 is an enlarged view partially in cross section of the proximalextremity of the medical device as shown in FIG. 1.

FIG. 4 is a cross sectional view taken along the line 4--4 of FIG. 3.

FIG. 5 is a cross sectional view taken along the line 5--5 of FIG. 3.

FIG. 6 is a side elevation of a view of a collar or skirt with itscylindrical extension utilized in the medical device shown in FIG. 1.

FIG. 7 is a view similar to FIG. 6 but rotated by 180°.

FIG. 8 is a isometric view of the cap utilized in the medical deviceshown in FIGS. 1 and 2.

FIG. 9 is a isometric view of the spring utilized in the counterassembly of the medical device shown in FIGS. 1 and 2.

FIG. 10 is an isometric view of the counter ring forming a part of themedical device shown in FIGS. 1 and 2.

FIG. 11 is a partial side elevational view of a tool similar to thatshown in FIGS. 1 and 2 partially in cross section showing anotherembodiment of a counter incorporating the present invention.

FIG. 12 is a cross-sectional view taken along the line 12--12 of FIG.11.

FIG. 13 is a cross-sectional view taken along the line 13--13 of FIG.11.

In general, the medical device consists of a tool having a proximalextremity. The proximal extremity of the tool includes a collar which isaffixed thereto and a cap. The cap includes a part which requiresreplacement and/or cleaning for each use of the tool. Cooperative meansis carried by the cap and the collar and includes a rotatable numberwheel and means for causing advancement of the number wheel and when thecap is separated from the collar so that the number wheel is advanced byone increment each time the cap is removed and/or replaced on the collarto give an indication of the number of times that the device has beenused or the number of uses remaining.

More particularly, as shown in drawings, the medical device 11 consistsof a replaceable and reusable tool 12 which is removably mounted in atool actuating and holding mechanism or tool actuator 13 which isprovided with the pistol grip 14 having a tubular extension 15 andhaving an actuating trigger 16 mounted therein. The actuator 13 can beof a type described in co-pending application, Ser. No. 07/806,666,filed Dec. 13, 1991, now U.S. Pat. No. 5,448,042 as explained thereinthe actuating and holding mechanism is adapted to have used therewith aplurality of removable tools of the type described in said co-pendingapplication. A typical tool 12 is shown in FIG. 1 and as shown thereinconsists of a grasper 21 of the type described in co-pendingapplication, Ser. No. 07/806,666, filed Dec. 13, 1991 now U.S. Pat. No.5,448,042. The grasper 21 is carried by an elongated rigid tubular shaft26 which is slidably mounted in a back up tube 27. A sleeve 28 isdisposed over the back up tube 27 and over a collar or skirt 31. Thecollar 31 is secured to the proximal extremity of the shaft 26. Thecollar 31 is provided with a plurality of circumferentially spaced-apartwindows 33 which are adapted to receive fingers 34 of a locking member36 carried by the tubular member 26. The collar 31 is provided with acylindrical extension 38 of reduced diameter which has an annularprotrusion 39 formed thereon.

A removable cap 41 is provided which is adapted to be secured to thecylindrical extension 38 as hereinafter described. Typically the cap 41carries a replaceable part which requires that it be replaced or cleanedspecially after each use of the tool 12. Thus, as shown, a resilientvalve 42 (see FIGS. 2 and 3) is removably mounted within the cap 41 in acylindrical recess 43 and forms a seal with the annular protrusion 39 onthe cylindrical extension 38. The cap 41 is provided with a centrallydisposed bore 46 which is in alignment with the valve 42 and with theshaft 26.

Cooperative mating means is provided for removably securing the cap 41to the cylindrical extension 38. The cooperative mating means includes acounter assembly 51 which includes a counter ring or wheel 52. Thecounter ring or wheel 52 is provided with a sloping surface having aplurality of circumferentially spaced-apart indicia in the form ofarabic numerals 53 as hereinafter described to indicate the number ofuses which are left rather than the number of uses which have occurredwith respect to the tool. However, the counter wheel 52 can be used tocount either up or down. Additional cooperative mating means areprovided for snapping the counter ring 52 onto the cylindrical extension38 and consists of an annular groove 54 in the counter ring 52 whichsnaps over an annular protrusion 57 on the cylindrical extension 38 toretain the counter ring 52 by preventing longitudinal movement whilepermitting rotational movement.

The cooperative mating means for securing the cap 41 to the cylindricalextension 38 comprises first and second L-shaped type recesses or slots61 and 62 with bayonet-type entries which are formed 180° apart in theexterior surface of the cylindrical extension 38 as shown in FIGS. 6 and7. As shown in those figures, each of the recesses or slots 61 and 62 isprovided with inlet portions 61a and 62a which are substantiallyfunnel-shaped. The portions 61a and 62a lead into portions 61b and 62b,respectively that extend directions parallel to the axis of thecylindrical extension 38. The portions 61b and 62b adjoin portions 61cand 62c, respectively and extend at right angles thereto orcircumferentially of the cylindrical extensions 38. Another annularrecess 63 is provided in the cylindrical extension 38 which is generallyin registration with the bayonet type recess 61 that extendscircumferentially in a direction at right angles to the axis of thecylindrical extension 38 and subtends an angle of approximately 90°.

The cooperative mating means also includes first and second buttons orprotrusions 66 in the cap 41 (FIG. 8) which are spaced 180° apart andwhich are adapted to seat in and mate with the recesses 61 and 62provided on the cylindrical extension 38. An L-shaped recess 67 isformed in the cap and extends inwardly from the distal extremity of thecap to provide a pawl 69 which has an inclined ramp 71 formed therein onthe open side of the cap 41 which is inclined outwardly in acircumferential direction.

Three cooperating spaced-apart arcuate ramps 72, 73 and 74 are providedin one end of the counter ring or wheel 52 as shown in FIG. 4 which areinclined upwardly or outwardly in a clockwise direction as viewed inFIG. 4 followed by a spaced apart arcuate recess 76 which is of uniformdepth. Arcuate portions 77, 78 and 79 of uniform height are disposedbetween the ramps 72, 73 and 74 and the recess 76. A longer arcuateportion 81 of the same height as portions 77, 78 and 79 is disposedbetween the end of the recess 76 and the commencement of the ramp 72. Astepdown 82 from the arcuate surface 81 occurs at the commencement ofthe ramp 72. This stepdown 82 represents the initial or starting pointfor counting as hereinafter described and has the pawl 69 positionedtherein as shown in FIG. 4. Additional stepdowns 83, 84 and 85 areprovided from the surfaces 77, 78 and 79 respectively into the arcuateramps 73 and 74 and into the recess 76.

The other side or end of the counter ring or wheel 52 is provided withan annular recess 86 and with a centrally disposed hole or bore 87 whichextends axially through the ring 52. A plurality of circumferentiallyspaced-apart arcuate ramps 88, 89, 91 and 92 are provided in the ring 52and are spaced approximately 70° apart. Radial stepouts 93, 94, 95 and96 are provided respectively for the commencement of the ramps 88, 89,91 and 92 and extend outwardly from the cylindrical surface defining thebore 87.

A slot 97 is also formed in the counter ring 52 and opens into the hole87 and is spaced approximately equidistant from the ramps 88 and 92. Asemicircular counter pawl 98 (see FIG. 9) is provided and is formed of asuitable material, such as stainless steel. It can have a suitablethickness, as for example, 0.005 inches and a suitable width as forexample, 0.070 inches. It is provided with an outwardly bent portion 98aat one end of an inwardly bent portion 98b at the other end. The portion98a is adapted to seat in the slot 97 whereas the portion 98b is adaptedto seat in a slot 99 provided at the base of the cylindrical extension38. As shown in FIGS. 4 and 5, a hole 101 extends through thecylindrical extension 38.

The cap 41 when assembled as shown in FIGS. 2 and 3 of the drawings isadapted to have mounted thereon a suction and irrigation adapter 106 ofa conventional type which has a cup-shaped member 107 frictionallyretained on the cap 41 and has a cylindrical extension 108 therein whichextends through the cap 41 and seats in the valve 42. The frictionalretention is aided by an annular protrusion 109 provided on the exteriorof the cap 41. The adapter 106 is provided with tubes 111 and 112 serveas an irrigation tube and a suction tube, respectively.

Operation and use of the medical device 11 with a counter therein forrecording usage may now be briefly described as follows. Let it beassumed that a tool 12 has been assembled in the manner shown in thedrawings and that it is desired to utilize the same in a hand heldactuator, as for example the actuator 13 hereinbefore described toperform a laparoscopic procedure. After the laparoscopic procedure hasbeen performed, the tool 12 can be removed from the actuator 13. Let itbe assumed that it is now desired to utilize the tool 12 in connectionwith another laparoscopic procedure and that before doing so it isdesired to clean and sterilize all parts of the tool. The cap 41 isremoved by rotating it in a counter clockwise direction by the thumb andthe index finger of the hand grasping the cap which has its cap pawl 69in engagement with the leading edge of the ramp 72 and causes thecounter ring or wheel 52 to rotate as the cap 41 is rotated. The nextdigit 53 appearing on counter ring 52 is now in registration with arrow116 provided on the skirt 31. The amount of rotation is determined bythe length of the slots 61c and 62c. While twisting the cap 41, thefingers of the hand can readily feel when the buttons 66 reach the endsof the slot portions 61c and 62c. The cap 41 then can be pulledproximally to cause the buttons or protrusions 66 to travel in the slotportions 61b and 62b to permit the cap to be separated from thecylindrical extension 38. The cap 41 with the valve 42 therein can bediscarded. A flushing cap (not shown) to which a syringe can be attachedis placed over the cylindrical extension 38 to flush out the interior ofthe tool 12. The flushing cap can then be removed with no effect on thecounter wheel 52. Thus, the flushing cap can be put in place and removedwithout affecting the counter wheel.

A new cap 41 with a new valve 42 therein is placed over and into thecylindrical extension 38 by registering the protrusions or buttons 66with the bayonet type entrance slot portion 61a and 62a and then pushingthe cap 41 inwardly over the cylindrical extension 38 so that theybottom out in the slot portions 61b and 62b. The cap 41 is then rotatedin a clockwise direction so that the buttons 66 travel in the slotportions 61c and 62c. Rotation of the cap 41 can continue until the cappawl drops off over the stepdown 83 into the deepest part of theinclined ramp 73. Further rotation of the cap 41 cannot occur becausethe buttons 66 are seated at the extremities of the slot portions 61cand 62c. The counter wheel 52 is prevented from being rotated in aclockwise direction by the use of the substantially semicircular counterpawl 98 which it has its end portion 98a seated against one of thestepouts 93-96.

The tool 12 is now ready to be sterilized with its new cap 41 and thevalve 42 therein. Typically, this sterilization can take place in aconventional autoclave where it is subjected to a temperature ofapproximately 275 degrees Fahrenheit.

After cleaning and sterilization, the tool 12 is ready for use and canbe placed into the actuator 13 and let it be assumed that it has in factbeen used. After use, the cap 41 is removed by rotating it in acounterclockwise direction. As this counterclockwise rotation occurs,cap pawl 69 engages the stepdown 83 of the ramp 73 and causescounterclockwise rotation of the counter wheel. Typically such movementcan subtend a certain angle as for example an angle of 76 degrees. Thelimit of the counter clockwise rotation is limited by the otherextremity of the slot portions 61c and 62c.

As the counter wheel 52 is rotated in a counterclockwise direction, theramp 89 engages the out turned portion 98a and depresses that portion ofthe counter pawl 98 into the recess 63 in the cylindrical extension 38.This continues until the portion 98a is released at the stepout 95permitting it to spring back into the deepest part of the ramp surface91. This juxtaposition of portion 98a of counter pawl 98 and stepout 95serves to prevent clockwise motion of the counter wheel 52. At thispoint, the buttons or protrusion 66 are at the end of the slot portions61c and 62c permitting the cap 41 with the valve 42 to be removed anddiscarded. After cleaning and flushing of the tool 12 as hereinbeforedescribed, a new cap 41 and a new valve 42, if applicable, can then bepositioned on the cylindrical extension 38 by causing the protrusions orbuttons 66 to enter into the L-shaped slots 61 and 62. Thereafter, thecap 41 is locked in position by rotating it in a clockwise direction.Because of the counter pawl 98 and shape of the ramps 72-74, and 76,rotation of the cap 41 in a clockwise direction cannot cause similarclockwise motion of the counter wheel 52. The counter wheel 52 is lockedin a predetermined clockwise position by the portion 98a engaging thestepout 95 at deepest portion of the ramp 91. Thereafter, the tool canbe sterilized hereinbefore described.

If it is desired to reutilize the tool 12 in another procedure, the cap41 and the valve 42 therein can be removed by rotation in acounterclockwise direction to advance the counter wheel 52 another digitafter which the cap 41 and the valve 42 therein can be discarded and anew cap with a new valve, if applicable, inserted therein and be placedon the extension and the same procedure repeated. This procedure can berepeated until the last digit has been reached on the counter wheelwhich means that the tool has been used to the extent of usage permittedwithin the warranty. After that point in time if the user stillcontinues to use the tool, the user is using it out of warranty and atthe user's risk. At the time, that the last position is reached, thepawl portion 98a drops into the recess 97 and remains there becausethere are no more ramps which are available on the counter wheel 52 topush the counter wheel pawl 98 into the recess 63. This preventsrezeroing of the counter wheel 52.

Another embodiment of a counter for recording usage of a tool is shownin FIGS. 11, 12 and 13. As shown therein, the skirt 31 with acylindrical extension 38 are substantially identical to the skirt 31 andthe cylindrical extension 38 hereinbefore described in connection withthe previous embodiments with the exception that an arcuate protrusion38a (see FIG. 13) has been provided on the outer surface of thecylindrical extension 38. A cap 41 identical to that hereinbeforedescribed is utilized with the cylindrical extension and is providedwith cooperative mating means of the type hereinbefore described for thecap 41 and the cylindrical extension 38.

In order to simplify construction of the counter assembly and to make itpossible to eliminate the counter pawl 98, a modified counter assembly121 has been provided which includes a counter wheel 122 and a counterindexer 123. The counter indexer 123 fits within the counter wheel 122and both fit over the cylindrical extension 38. The counter wheel 122and the counter indexer 123 can be formed of a suitable plastic materialsuch as ULTEM 1000 which is a plastic suitable for medical uses. Thecounter indexer 123 is provided with an annular body 124 which has alarge opening 126 therein to accommodate the cylindrical extension 38.It is also provided with a planar wall 127 which travels on the skirt31. It is also provided with another wall 128 parallel to the wall 127.

The counter wheel 122 is provided with an annular body 131 which has awall 132. The body 131 is provided with a bore 133 which corresponds tothe size of the cylindrical extension 38 so that the counter wheel 122can rotate thereon. The body 131 is provided with a sloping exteriorsurface 136 which carries therein indicia 137 going from 0-10 as shownin approximate positions in FIG. 12. The body 131 is provided with anannular recess 138 which is shaped to receive the body 124 of thecounter indexer 123 with a relatively close fit. Cooperative means iscarried by the counter wheel 122 and the counter indexer 123 to assurethat they are registered properly with respect to each other when theyare assembled and fastened together with suitable means such as by anadhesive or solvent (not shown). This cooperative registration meansconsists of an upstanding lug 141 which is provided on the counterindexer 123 which is disposed in a recess 142 in the counter wheel toprovide a precise rotational relationship between the counter indexer123 and the counter wheel 122. If desired, the counter indexer 123 andthe counter wheel 122 may be formed in one piece. An inwardly extendingprotrusion 143 is provided on the counter indexer 123 which is used fora purpose hereinafter described.

A plurality of circumferentially spaced arms 146 are provided as a partof the counter indexer 123 and are formed integrally therewith. Slots147 are provided behind the arms to permit the arms to be deflectedinwardly into the slots 147 as hereinafter described. As shown in FIG.13, these arms 146 are adapted to be engaged by the protrusion 38acarried by the cylindrical extension 38. Thus, it can be seen that thearms 146 are cammed outwardly in a radial direction by the protrusion38a engaging the arms as the counter wheel 122 and the counter indexer123 are rotated in a counterclockwise direction. When the protrusion 38aclears each of the arms 146 the arms 146 snap back into their normalposition and serve as stops to prevent rotation of the counter wheel 122and the associated counter indexer 123 in a clockwise direction.

The other side of the body 131 is provided with a wall 151 in whichthere are provided a plurality of ramps 152, as for example, ten if itis desired to have nine counts on the counter assembly 121. These ramps152 are formed by step downs 153 from the wall 151 with the ramps 152,when viewed in the clockwise direction shown in FIG. 2, being inclinedupwardly and outwardly until they reach the surface or wall 151. Anarcuate recess or trough 156 is provided between the nine ramps 152.

Operation and use of the tool with the counter assembly 121 hereinbeforedescribed is very similar to that hereinbefore described for use withthe counter assembly 51. A cap 41 with a valve 42, if applicable, wouldbe inserted over and into the cylindrical extension 38 with the buttons66 in engagement with the L-shaped recesses 61 and 62 provided in thecylindrical extension 38. Each time that the cap 41 is removed after useof the tool, the cap 41 is rotated in a counterclockwise direction withthe cap pawl 69 engaging a stepdown 153 into the recess 152 and causingrotation of the counter wheel 122 and the counter indexer 123. Travel isarrested when the buttons 66 reach the portions 61b and 62b of theL-shaped slots 61 and 62. The counter assembly 121 cannot be rotated ina clockwise direction because the extremities of the arms 146 engage theprotrusion 38a to prevent such rotation.

The cap 41 can then be slipped off with the buttons traveling throughthe slot portions 61b and 62b. After cleaning, a new cap 41 with a newvalve 42, if applicable, therein can then be placed on the tool and thetool sterilized in the manner hereinbefore described. After the tool hasbeen sterilized and reused, the cap can be removed in the mannerhereinbefore described by having the cap pawl 69 engage the next stepdown 153 to again advance the counter wheel 122 and the counter indexer123 by another increment. The cap 41 can then be removed and replaced ashereinbefore described. This procedure can continue until the tenth timeat which the time the protrusion 38a on the cylindrical extension 38ends up between the inwardly extending protrusion 143 provided on thecounter indexer 123 and the distal extremity of the nearest arm 146.This prevents rezeroing of the counter wheel 122. The tool, however, canstill be used by removing the cap and inserting a new cap. The count,however, will remain the same to indicate that nine uses have occurredand that the warranty has expired. The counter wheel 122 can not rotatebecause it is locked between protrusion 143 and the last pawl of theindexer 123. The last ramp is in fact not a ramp but of equal depththroughout. Thus, it will not deflect the cap pawl and allow it to dropinto the next ramp but only allows the cap pawl limited travel within itwhich has no effect on advancing the counter wheel 122.

It is apparent from the foregoing that there has been provided a counterfor recording usage on medical tools and devices. The outline of thecounter fits within the confines of the tool and is very compact. Itsconstruction is relatively simple and is comprised of few parts so thatit can be economically manufactured.

What is claimed is:
 1. A surgical device having a counter for recording usage, comprising a tool and a tool actuator having the tool removably mounted thereon and including means for actuating the tool, said tool having a proximal extremity, said tool comprising a collar and a cap removable mounted on the collar, said cap including a part which requires replacement and/or cleaning for each use of the tool, cooperative mating means carried by the cap and the collar and including a rotatable counter wheel having a plurality of circumferentially spaced apart numbers thereon and also including means for causing advancement of the counter wheel from one number to the next number when the cap is separated from the collar so that the counter wheel is advanced by one increment each time the cap is removed from the collar to give an indication of the number of times that the device has been used.
 2. A device as in claim 1 wherein said cooperative mating means includes means engaging said counter wheel and permitting rotation of said counter wheel in one direction and preventing rotation of said collar in an opposite direction.
 3. A device as in claim 1 wherein said collar is provided with a cylindrical extension and wherein said counter wheel is rotatably mounted on the extension of said collar, said cooperative means including at least one L-shaped slot and a protrusion for traveling in said L-shaped slot, the cooperative means carried by the collar being disposed on the cylindrical extension.
 4. A medical device as in claim 1 wherein said counter wheel is provided with a plurality of circumferentially spaced-apart ramps and stepdowns entering into the ramps and wherein said cap is provided with a cap pawl adapted to travel on said ramps and engage said stepdowns.
 5. A device as in claim 4 wherein said cooperative mating means for permitting rotation of the counter wheel in one direction and preventing rotation of the counter wheel in the opposite direction includes a yieldable member adapted to be moved out of engagement during incremental rotation of the counter wheel and preventing rotation of the counter wheel in the opposite direction.
 6. A surgical device having a counter for recording usage comprising a tool having a proximal extremity, said tool having a collar affixed thereto and a cap, said cap having a centrally disposed flow passage therein through which a fluid can be introduced and a valve for closing off said flow passage, cooperative mating means carried by the cap and the collar including a counting mechanism for displaying a plurality of sequential numbers connoting usage of the device, said counting mechanism including a movable member advanceable by increments to display each of said sequential numbers one-by-one in sequence, said counting mechnism also including means for causing advancement of the movable member to display the next sequential member when the cap is separated from the collar so that the movable member is advanced by one increment each time the cap is removed from the collar to give an up-to-date indication of the number of times the device has been used. 